United States 

Department of 

Agriculture

Animal and 

Plant Health 

Inspection 

Service

June 2013

Final Regulatory Flexibility Analysis

Affirmation of Interim Final Rule

Docket Number: 00-108-11

RIN 0579-AB35

Chronic Wasting Disease Herd Certification 

Program and Interstate Movement of Farmed 

or Captive Deer, Elk, and Moose

Policy & Program Development

Policy Analysis & Development
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Summary

This final rule affirms prior regulatory actions that established a voluntary Herd 

Certification Program (HCP) for the control of chronic wasting disease (CWD) in farmed or 

captive cervids (deer, elk, and moose) in the United States. The program regulations include

CWD monitoring and testing requirements, and set minimal requirements for interstate 

movement that will not preempt more restrictive State or local laws or regulations. As at present, 

herd owners’ interstate marketing decisions may need to account for dissimilar State CWD 

certification regulations. 

Herd owners who choose to participate in the Herd Certification Program will have to 

meet program requirements for animal identification, testing, and herd management. Other than 

for cervids moving to slaughter or for research, those that move interstate must be from Certified 

herds that have been monitored for a period of at least 5 years and that have not been 

epidemiologically linked to herds where CWD has been diagnosed, or captured from a wild 

cervid population that has been documented to be low risk for CWD based on a surveillance 

program. 

Some herd owners may be adversely affected by the 5-year monitoring requirement for 

interstate movement; however, available research indicates that this minimum period of 

monitoring is necessary to provide an adequate level of protection against the spread of CWD. 

Most researchers agree that CWD manifests itself within 5 years if the disease is present in a 

herd of farmed or captive cervids. Many herd owners have been participating in State-level 

CWD HCPs for at least 5 years and will have met this requirement as a result of being enrolled 

in a State program that becomes an Approved State HCP in the national CWD HCP.
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Producers who participate in the Herd Certification Program will be required to maintain 

a complete inventory of their herds, with verification by APHIS or State officials. A physical 

inventory of the animals will be required at the time a herd is enrolled in a CWD certification 

program and thereafter the animals will need to be physically assembled for inventory within 3 

years of the last physical inventory. An annual herd inventory—including a review of owner 

records and an observation of the herd’s unrestrained animals in a viewable, enclosed area—will 

continue to be required, but the animals will not necessarily need to be physically assembled and 

restrained.

The inventory cost is estimated to average about $25 to $30 per deer or elk, including the 

animals’ physical inventory once every three years and use of eartags for identification. (We do 

not know of any farmed or captive moose herds.) Values of farmed or captive deer and elk range 

widely, depending on the type of animal and market conditions. Based on average per animal 

values of $2,000 for deer and $2,200 for elk, annual inventory costs are estimated to average less 

than 2 percent of the value of farmed or captive deer and elk. 

All on-farm cervid mortalities, and any cervids on herd inventories sent to slaughter and 

hunt facilities, must be tested to achieve certified status. Thereafter, all on-farm mortalities of 

Certified cervids will be required to be tested for CWD, to maintain Certified status. There also

will be optional confirmatory DNA test provisions for animals that test CWD-positive. CWD 

testing will entail submission of the carcass or whole head for tissue sampling and testing, or 

collection of the tissue samples by State officials, APHIS employees, accredited veterinarians, or 

State-certified or -designated CWD sample collectors. The estimated cost is about $150 per 

sample, equivalent to about 8 percent of the average value of a farmed or captive deer and about 

7 percent of the average value of a farmed or captive elk. CWD testing of cervids is recognized 
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by APHIS, the States, and cervid herd owners as essential to successful control of this disease. 

Owners who choose confirmatory DNA testing will consider it a benefit, as evidenced by their 

payment for this voluntary, optional test.

Most cervid operations are small entities. The rule will have a positive overall economic 

impact on affected entities large and small, and for the U.S. cervid industries generally, in 

controlling the spread of CWD and facilitating interstate and international trade in cervids and 

cervid products. 
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Table of Contents

Summary.............................................................................................................................. i

Introduction......................................................................................................................... 1

Need for and Objectives of the Rule................................................................................... 5

Significant Issues raised by Public Comment in response to the Initial Regulatory

Flexibility Analysis............................................................................................................. 6

Comments filed by the Small Business Administration in response to the Proposed Rule 6

Potentially Affected Small Entities..................................................................................... 6

Projected Reporting, Recordkeeping, and Other Compliance Requirements..................... 7

Steps taken by APHIS to minimize Significant Economic Impacts on Small Entities ...... 7

References........................................................................................................................... 9
1

Introduction

The Regulatory Flexibility Act requires agencies to evaluate the potential effects of their 

proposed and final rules on small businesses, small organizations and small governmental 

jurisdictions. This final regulatory flexibility analysis describes expected impacts of this rule on 

small entities, as required by section 604 of the Act.

Chronic wasting disease (CWD) is a transmissible spongiform encephalopathy (TSE) of 

cervids (deer, elk, and moose). TSEs are caused by abnormal proteins known as prions. First 

recognized as a clinical "wasting" syndrome in 1967 in mule deer in a wildlife research facility 

in northern Colorado, CWD was identified as a TSE in 1978. It is characterized by chronic 

weight loss leading to death. There is no known relationship between CWD and other TSEs of 

animals or people. 

The disease was first detected in U.S. farmed elk in 1997, and was also diagnosed in a 

wild moose in Colorado in 2005. As of April 2013, CWD has been confirmed in wild deer and 

elk in 18 States and in 40 farmed elk herds and 20 farmed deer herds in 13 States.

This final rule affirms an interim final rule published in June 2012. The interim final rule 

amended a July 2006 final rule that established a Federal CWD Herd Certification Program

(HCP) to control this disease in farmed or captive cervids. The July 2006 final rule set forth for 

participating owners herd management regulations, including CWD monitoring and testing 

requirements, and set interstate movement restrictions. We are adopting the interim final rule 

without changes.
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Deer and elk are farmed for breeding stock, velvet antler, meat, and sales to game parks 

and exhibits. Velvet antler, considered a medical/dietary aid, is produced primarily for Asian 

markets. Deer and elk meat, or venison, is a low-fat, low-cholesterol product that is marketed 

primarily to gourmet restaurants, for consumption by health conscious dieters. The breeding 

stock market satisfies the need for semen to be used for artificial insemination, replacement and 

start-up animals. There are no known commercial moose farming operations in the United 

States, although such operations may emerge in the future.

Hard statistical data on the deer and elk farming industries is, at best, limited. The two 

major industry associations – the North American Elk Breeders Association (NAEBA) and the 

North American Deer Farmers Association (NADFA) – compile very little data apart from their 

own membership, and only sparse data on deer and elk farms are included in Census of 

Agriculture data.

In 2007, there were 68,251 elk on 1,917 elk farms, compared to 97,901 elk on 2,371 

farms in 2002, that is, there were 5-year declines of 30 percent and 19 percent in the number of 

elk and number of farms, respectively. According to NAEBA, the number of elk per farm varies, 

from a high of “500 plus” for commercial farms to a low of about 10 for hobby farms. The value 

of each elk held also varies, depending on the type of animal (e.g., bull, cow, calf), market 

conditions, and other factors. In 2012, NAEBA estimated the average value of an elk at $2,200, 

with a typical high-end value of about $6,500. Based on the estimated average of $2,200 per 

animal, the value of all 68,251 elk on U.S. farms in 2007 is estimated to have been about $150 

million (68,251 x $2,200). 

In 2007, there were 269,537 deer on 5,654 deer farms, compared to 286,863 deer on 

4,901 farms in 2002, that is, over this 5-year period, the number of farmed deer declined by 6 
3

percent, but the number of farms increased by 15 percent. The number of deer per farm varies, 

from a high of about 3,000 for commercial farms to a low of about 5 for hobby farms. The value 

of deer also varies, depending on the type and breed (e.g., red, white-tailed, fallow) and market 

conditions. A NADFA estimate reported in the economic analysis for the July 2006 final rule 

put the average per animal value of all deer on member farms at $1,687, with the high-end value 

at $4,000 and the low-end value at $375. Based on an average of $2,000 per animal, the value of 

all 269,537 deer on U.S. farms in 2007 is estimated to have been about $539 million (269,537 x 

$2,000). 

With publication of this final rule and concurrent removal of the suspension of the July

2006 final rule, farmed or captive deer and elk herd owners who choose to participate in the 

voluntary national CWD Herd Certification Program will have to meet program requirements for 

animal identification, testing, and herd management. The program will be a cooperative effort 

by APHIS, State animal health and wildlife agencies, and cervid herd owners.

State responsibilities will include restricting interstate movement of farmed or captive 

deer and elk; imposing quarantine and movement restrictions; and conducting traceback and 

epidemiological investigation of CWD-positive, CWD-exposed, and CWD-suspect cervids; 

requiring premises identification and animal identification of all participating herd owners; and 

testing of all animals that die or are killed and requiring appropriate disposal of the carcasses. 

Herd owners will be responsible for identifying each animal in their herds through 

approved means of identification before they reach 12 months of age, when they are moved off 

the premises, or when a herd inventory is conducted. They must also maintain an inventory that 

includes records on the species, age, and sex of each animal; the date of acquisition and source of 
4

each animal that was not born into the herd; the date of disposal and destination of animals 

removed from the herd; and the animal identification associated with each animal. 

A physical inventory will be required at the time a herd is enrolled in a CWD program, 

after which a physical inventory will need to be performed within 3 years of the previous 

physical inventory. An annual herd inventory—including a review of owner records and an 

observation of the herd’s unrestrained animals in a viewable, enclosed area—will continue to be 

required, but the animals will not necessarily need to be physically assembled and restrained.

Herd owners must also maintain perimeter fencing adequate to prevent CWD from being 

spread through contact with wild cervids, and introduce into the herd only animals from other

HCP herds so that those animals pose a known risk of infection with CWD. Herd owners will be 

required to report to APHIS or the State all animals that escape or disappear, and all animals that 

die or are killed and make their carcasses available for tissue sampling and testing. The 

regulations will allow for optional confirmatory DNA test provisions for animals that test CWDpositive. 

Participating herds will be assigned a herd status based on how long they have conducted 

continuous CWD surveillance in the program without any CWD positive findings. Herds 

already participating and in compliance in an Approved State HCP will receive credit. After 5 

years of participation with no CWD-positive or CWD-exposed animals, the herd will be 

designated a Certified herd. Herds that contain CWD-positive or CWD-exposed animals will 

lose their status and may only reenroll in the program after entering into a herd plan designed to 

address possible sources of infection and monitor the animals for CWD. Herds containing 

CWD-suspect animals will be placed in suspended status and further investigated to determine 

appropriate actions. A herd may add animals of the same or higher status without changing its 
5

status, but if it adds animals of a lower status, the receiving herd reverts to the program status of 

the sending herd. Adding animals from a nonparticipating herd restarts the herd's participation in 

the program.

The following animals will be eligible for interstate movement: farmed cervids from 

Certified herds, if accompanied by a certificate; free-ranging (wild) cervids captured for 

interstate movement or release, if identified with two forms of animal identification – including 

one official identification – and if the source population has been documented to be low risk for 

CWD based on a surveillance program; cervids moved for slaughter, if identified and 

accompanied by a certificate; research animals, if accompanied by a permit granted by the 

Administrator; and animals approved on a case-by-case basis by the Administrator. The July

2006 final rule, as amended, will set minimum requirements for interstate movement of farmed 

or captive cervids with respect to CWD, but will not preempt more restrictive State laws and 

regulations, with the exception of cervids transiting a State en route to another State.

Need for and Objectives of the Rule

The presence of CWD in cervids causes significant market losses to U.S. producers. 

Domestic prices of elk and deer are depressed by fear of CWD. Canada prohibits the 

importation of elk from Colorado and Wyoming and now requires that other cervids be 

accompanied by a certificate stating that CWD has not be diagnosed in the herd of origin. The 

Republic of Korea has suspended the importation of deer and elk and their products from the 

United States and Canada.

APHIS estimates that through FY 2011, approximately 140 farmed cervid premises 

having approximately 7,500 animals that were either CWD-positive or CWD-exposed have been 

depopulated using APHIS indemnity funding. The Herd Certification Program will enable 
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timely identification of herds infected with CWD. The program’s establishment of herd 

management practices and minimum requirements for the interstate movement of farmed or 

captive deer, elk, and moose will help control the incidence of CWD and prevent its spread.

Significant Issues raised by Public Comment in response to 

the Initial Regulatory Flexibility Analysis

The interim final rule specifically requested comments with respect to preemption of 

State and local laws and regulations regarding CWD. There were no significant issues raised by 

the public in response to the initial regulatory flexibility analysis.

Comments filed by the Small Business Administration in 

response to the Proposed Rule

There were no comments filed by the Small Business Administration in response to the 

interim final rule.

Potentially Affected Small Entities

This rule will directly affect cervid herd owners. As reported in the Census of 

Agriculture, in 2007 there were 1,917 elk farms that had a total elk population of 68,251, and 

5,654 deer farms that had a total of 269,537 deer. We do not have information on the size 

distribution of these holdings. However, it is reasonable to assume that most of these operations 

were small in size, based on the Small Business Administration's (SBA) standard of annual gross 

receipts of not more than $750,000 for the industry category NAICS 112990, All Other Animal 

Production. In 2007, there were 61,973 U.S. farms categorized within NAICS 112990, a 

classification composed of establishments primarily engaged in raising certain animals 

(including deer and elk, but excluding cattle, hogs and pigs, poultry, sheep and goats, animal 
7

aquaculture, apiculture, horses and other equines, and fur-bearing animals). For all 61,973 

farms, the average market value of agricultural products sold in 2007 was about $38,205, well 

below the SBA's small-entity threshold of $750,000.

To the extent that the rule prevents the spread of CWD in farmed cervids in the United 

States, herd owners will benefit over the long term. While helping to prevent disease spread, the 

rule will also provide herd owners with increased access to out-of-State markets. By providing a 

minimum basis for equivalency between State programs, the rule will facilitate the safe 

movement of animals between States. It will also signal that a safe cervid market exists in the 

United States that can be tapped internationally for specialized products such as antler velvet. 

Herd owners who sell their cervids in-State will benefit as well, since the Herd Certification 

Program will reduce their disease risk when receiving animals from other States. 

Projected Reporting, Recordkeeping, and Other Compliance 

Requirements

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 

3501 et seq.), we published a notice in the Federal Register on January 24, 2012 (77 FR 3434-

3435, Docket No. APHIS-2011-0032), announcing our intention to reinstate the information 

collection associated with the July 2006 final rule and soliciting comments on it. The changes 

made to the July 2006 final rule themselves have no new mandatory reporting, recordkeeping, or 

other compliance requirements for U.S. entities. 

Steps taken by APHIS to minimize Significant Economic 

Impacts on Small Entities
8

Based on our review of available information, APHIS does not expect the rule to have a 

significant economic impact on small entities. In the absence of significant economic impacts, 

we have not identified alternatives that would minimize such impacts.
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References

Census of Agriculture, 2007, 

http://www.agcensus.usda.gov/Publications/2007/Full_Report/index.asp

Census of Agriculture, 2002, 

http://www.agcensus.usda.gov/Publications/2002/Volume_1,_Chapter_1_US/

Economic Census, 2002, http://www.census.gov/econ/census02/

Small Business Administration. A Guide for Government Agencies How to Comply with 

the Regulatory Flexibility Act. http://www.sba.gov/advo/laws/regflex.html

Small Business Administration. Small Business Standard Match to North American 

Industry Classification System http://www.sba.gov/size/sizetable2007.html